Mechanisms Underlying the Protective Vascular Effects of Dietary Potassium in Humans

NCT ID: NCT04101188

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-16

Study Completion Date

2025-07-31

Brief Summary

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Americans continue to consume high amounts of sodium. Potassium is notable for its blood pressure lowering effects but less is known regarding its effect on the vasculature. This investigation seeks to determine the role of dietary potassium on the vasculature in the presence of a high sodium diet in salt-resistant adults.

Detailed Description

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Significant public health efforts have been made towards salt reduction but most have met with failure. Dietary factors such high sodium/low potassium diets contribute to the development of cardiovascular diseases (CVDs) such as atherosclerosis and high blood pressure (BP). This is important as CVD is the number one killer in the U.S. While the role of these two nutrients on BP is widely accepted, their impact on the vasculature has received less attention. Endothelial dysfunction, characterized by impaired dilation, is an important non-traditional risk factor for atherosclerosis. Evidence supporting potassium's beneficial role on vascular health remains unclear although it may be more effective in the presence of a high sodium diet. A purported mechanism responsible for sodium-induced vascular dysfunction is overproduction of reactive oxygen species (ROS) resulting in reduced nitric oxide (NO) production/bioavailability. Additionally, high sodium diets have been shown to stiffen the endothelium. This investigation will evaluate the vascular effects of dietary potassium during a high salt diet including its impact on sodium-induced oxidative stress and endothelial cell stiffness.

Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will complete each arm. It is a crossover, randomized design.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate Potassium/Low Sodium

Subjects will be provided with a diet that is moderate in potassium and low in sodium.

Group Type EXPERIMENTAL

Moderate Potassium/Low Sodium Diet

Intervention Type OTHER

Consumption of 10 days of a diet moderate in potassium and low in sodium.

Moderate Potassium/High Sodium

Subjects will be provided with a diet that is moderate in potassium and high in sodium.

Group Type EXPERIMENTAL

Moderate Potassium/High Sodium Diet

Intervention Type OTHER

Consumption of 10 days of a diet moderate in potassium and high in sodium.

High Potassium/High Sodium

Subjects will be provided with a diet that is high in both potassium and sodium.

Group Type EXPERIMENTAL

High Potassium/High Sodium Diet

Intervention Type OTHER

Consumption of 10 days of a diet high in potassium and high in sodium.

Interventions

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Moderate Potassium/Low Sodium Diet

Consumption of 10 days of a diet moderate in potassium and low in sodium.

Intervention Type OTHER

Moderate Potassium/High Sodium Diet

Consumption of 10 days of a diet moderate in potassium and high in sodium.

Intervention Type OTHER

High Potassium/High Sodium Diet

Consumption of 10 days of a diet high in potassium and high in sodium.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy
* normal blood pressure
* normal resting ECG

Exclusion Criteria

* hypertension
* history of heart disease
* diabetes
* kidney disease
* obese (BMI ≥30)
* significant weight changes in the last 6 months
* use of tobacco products
* pregnant
* on a special diet (gluten free; vegan)
* take any medications for the above conditions
* endurance trained athletes
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Delaware

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon L Lennon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Delaware

Locations

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University of Delaware

Newark, Delaware, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Liza J Walker, BS

Role: CONTACT

(302)831-3181

Shannon L Lennon, PhD

Role: CONTACT

3028312798

Facility Contacts

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Liza Walker, BS

Role: primary

302-831-3181

Shannon L Lennon, PhD

Role: backup

3028312798

Other Identifiers

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1472577

Identifier Type: -

Identifier Source: org_study_id

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